Dr. Bernie Zeiher, president of development at Astellas Pharma, recently addressed the use of biomarkers in the development of precise and specific treatments for patients.
Biomarkers are tools that are used for diagnosing disease, monitoring the progression of disease, and checking the reaction that a body is having toward a treatment being administered.
In addition to the plethora of uses that biomarkers already have, they may also be highly useful in decisions regarding what medications certain patients would most benefit from.
"In the case of oncology, if you’re targeting a tumor that has a particular mutation, you’d run the test before they’re enrolled and see if they have that mutation, and if they are, they’re eligible for treatment,” Zeiher said.
The Prescription Drug User Fee Act adds to the FDA's biomarker qualification process and works toward using biomarkers in the drug development processes.